Kornimate/medical-research-clean huggingface dataset:
management of joint pain associated with osteoarthritis of the knee with association of plant extracts.

Conditions: Gonarthrosis

Summary: the aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of curcuma longa, boswellia serrata and porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.

for this study, 126 patients are going to be included. they will have a supplementation of cartimotil fort®, from 1 to 4 capsules per day during 90 days. on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (dn4). on the other hand, patients complete the osteoarthritis symptom inventory scale (oasis) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). he completes the patient global impression of improvement (pgii), the minimal clinically important improvement (mcii) and the acceptable symptomatic statement (pass) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).

Eligibility criteria:
inclusion criteria: * vas of pain : minimum 5/10 on walking or 4/10 at rest * patients with a negative pass (patient considering that the symptomatic state is not acceptable) * suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the kellgreen scale - clinical examination) * having agreed to participate in the investigation after receiving information from the investigator exclusion criteria: * patients with rheumatological disorders other than osteoarthritis * patients for whom knee surgery is planned within 3 months * patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month * patients with a bmi greater than 35 * patients with chronic pain that can interfere with knee osteoarthritis pain * patients with reduced mobility or bedridden * patients with cognitive impairments not able to participate in the study * patients with known allergies to any of the ingredients of cartimotil fort® * pregnant or breastfeeding patients * patients who do not wish to participate in the study.
corneal endothelium after glaucoma surgery

Conditions: Glaucoma; Corneal Damage; Intraocular Pressure

Summary: the purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and ahmed glaucoma valve implant surgery prospectively. change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.

to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and ahmed glaucoma valve implant surgery prospectively. specular microscopy using non-contact type specular microscope (noncon robo sp-8000, konan medical inc., tokyo, japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. all examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. the follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.

Eligibility criteria:
inclusion criteria: * patients who need glaucoma surgery for intraocular pressure control exclusion criteria: * congenital glaucoma * pre-existing corneal abnormality * lost from follow up without any ocular problem within 6 months from surgery

Keywords: corneal endothelial cell specular microscopy glaucoma implant surgery ahmed glaucoma valve trabeculectomy
pilot assessment of lopinavir/ritonavir and maraviroc

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Summary: this is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in hiv patients failing their initial antiviral therapy.

as long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. this study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Eligibility criteria:
inclusion criteria: * hiv viral load \> 1,000 on current antiviral medications * no resistance to study medications * over 18 years of age exclusion criteria: * hepatitis b co-infection * pregnancy * previous therapy with either of the study medications * ongoing substance abuse * significant history of other physical disease

Keywords: acquired immunodeficiency syndrome hiv aids treatment experienced
the effect of fibrate therapy in two patients with neutral lipid storage disease with myopathy (nlsdm)

Conditions: Neutral Lipid Storage Disease

Summary: neutral lipid storage disease with myopath (nlsdm) is a disease caused by a defect in the pnpla2 gene encoding atgl. patients with nlsdm accumulate triglycerides and exhibit muscle weakness, cardiac failure and hepatosteatosis. most of these patients die at young age due to cardiac failure. not much is known about the underlying mechanisms, though recently it was discovered that ppar activation in atgl-/- mice was impaired leading to decreased mitochondrial function, lipid accumulation and cardiac failure resulting in death at young age. activation of ppars, by treatment with fibrates rescued the phenotype and reduced mortality rates in these mice. these findings may have a major impact for patients with nlsdm if these results can be translated to humans. therefore, the investigators would like to evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac function in patients with nlsdm. patients will be treated with fibrates during a period of 28 weeks. baseline measurements will be performed prior to the study and after treatment. cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity will be assessed during these baseline measurements.


Eligibility criteria:
inclusion criteria: * suffering from nlsdm

Keywords: nlsdm lipid accumulation
intravenous lidocaine and postoperative outcomes after cardiac surgery

Conditions: Atrial Fibrillation

Summary: this study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

subjects undergoing cardiac surgery are randomized into one of two groups. * group 1: intravenous lidocaine group * group 2: intravenous placebo group either lidocaine or placebo is administered throughout surgery and 24 hours after surgery. patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

Eligibility criteria:
inclusion criteria: * age 18-90 years old * scheduled for cardiac surgery requiring cardiopulmonary bypass * written informed consent exclusion criteria: * off-pump surgical procedures * anticipated deep hypothermic circulatory arrest * any contraindications to the proposed interventions including lidocaine allergy * history of preoperative atrial fibrillation * baseline screening revealing preexisting dementia or delirium * preoperative liver failure defined as child-pugh score \> 6

Keywords: cardiac surgery lidocaine quality of life
a multi-center study of detection of low ventricular ejection fraction

Conditions: Cardiac Disease

Summary: this is a multi-site, retrospective study to evaluate the performance of a locked ai-based algorithm for detection of left ventricular systolic dysfunction. a prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ecg paired with an echocardiogram with lvef information within 30 days of the date of the ecg. the ai-ecg lvsd algorithm will be applied on all ecgs and diagnostic performance features for the detection of lvsd will be estimated using the provided paired lvef value (low lvef as the reference label). performance will also be assessed in subgroups of subjects determined by demographic and clinical factors.

following institutional review board approval, 12,000 12-lead ecg's paired with an echocardiogram with lvef information within 30 days of the date of the ecg will be collected across three enrolled sites. each site will provide data from up to 4000 enrolled subjects that meet the inclusion criteria. no other demographic characteristics or enrichment will be considered in the selection of subjects in order to best represent the general population for that site. sites will securely transfer the data to a centralized repository for processing. once data is collected, the device will be used to analyze the ecg data for all enrolled subjects without reference or access to the echocardiogram data. the device will display a binary 36 prediction of the likelihood of lvef less than or equal to 40%. results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.

Eligibility criteria:
inclusion criteria: - adult subjects with or without known cardiac disease who are either inpatients or outpatients with ecgs and an echocardiogram within 30-days of the ecg date. exclusion criteria: * no research authorization provided * an ecg signal shorter than 10 seconds or that is not interpretable * an echocardiogram is considered technically challenging * only qualitative interpretation of left ventricular systolic function available (i.e., "decreased ef") without a numerical value. * a paced rhythm
triverity in the diagnosis and prognosis of emergency department patients with suspected infections and suspected sepsis

Conditions: Respiratory Tract Infections; Urinary Tract Infections; Intra-Abdominal Infections; Skin and Soft Tissue Infection; Suspected Meningitis/Encephalitis or Any Other Infection; Sepsis

Summary: this study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause.


Eligibility criteria:
inclusion criteria: 1. age \>18 year 2. suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms or, suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms: * heart rate: \>90 beats/ minute * temperature: \>38 c or \<36c * respiratory rate: \>20 breaths / minutes or pao2 of \<60 mmhg or spo2 \<90% * systolic blood pressure: \<100 mmhg * altered mental status: per clinical exam 3. able to provide informed consent, or consent by legally authorized representative. exclusion criteria: participants will be ineligible for this study if they meet any of the following criteria: 1. patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. participants will not be excluded for use of: 1. antiviral treatment for hiv infection and hepatitis b and hepatitis c 2. topical antibiotics, topical antiviral or topical antifungal agents 3. anti-herpes prophylaxis aiding suppression of a recuring herpes infection 4. peri-operative (prophylactic) antibiotics 5. a single dose of antimicrobials during the present ed visit (\<10h before blood draw); note single dose can be considered mono or combination therapy, wherein combination is administered as part of local standard of care and only one dose of each medication is administered within the allowable 10-hour window 2. patients receiving palliative or hospice care, or those receiving limited interventional care. 3. prisoners, mentally disabled, or unable to give consent. should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient. 4. patients receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. a. subjects that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial. 5. patients previously enrolled in the present clinical trial.

Keywords: infection mrna procalcitonin c-reactive protein lactate
a clinical trial using a new medical device to evaluate its impact on iv care and clinical complications

Conditions: IV Catheter-Related Infection or Complication

Summary: a clinical trial comparing two groups of patients that are randomized into one group having safebreak vascular attached to their peripheral iv lines and a second control group that receives the current standard of care (no safebreak vascular) to determine safebreak vascular's impact on iv clinical care and complications.

this randomized clinical trial's goal is to determine safebreak vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral iv line, on iv clinical care and complications.

Eligibility criteria:
inclusion criteria: * all patients admitted into the participating hospital units * patients of any gender may participate * participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent * patients must have peripheral iv catheter access or need and are planned to have peripheral iv catheter access placed that is anticipated to last a minimum of 24 hours. * patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion * the patients must be at least 18 years of age with no upper age limit exclusion criteria: * unable to obtain informed consent or without an available legally authorized representative or next of kin to provide surrogate informed consent * age less than or equal to 17 * patient on comfort care only * predicted to have an iv infusion that lasts less than 24 hours * patient admitted from the emergency department refuses to have new peripheral iv catheter placed by iv team * patient has two or more peripheral iv catheters at the same time * patient enrolled in a subject drug or device study at the time of enrollment * investigator discretion that patient is not suitable for the study * patient is covid-19 positive * patient is receiving an iv infusion with gravity tubing

Keywords: iv care iv complication
acute medical admissions of elderly patients (elder)

Conditions: Geriatric Disorder

Summary: to evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in a quick diagnostic unit (qdu) compared to the department of internal medicine (dim). a qdu is a medical short stay unit (ssu).

the danish emergency care system is undergoing major changes; emergency departments (ed) are now centralised at fewer hospitals, thus the ed now serve as the single point of entry for all acute patients. another initiative, has been the establishment of a quick diagnostic unit (qdu) as a subunit in the ed. the qdu is a ward for fast track diagnostics and treatment of stable medical patients that is believed to optimise in-hospital care by quicker diagnosis and shorter hospitalisations, and minimise time for patients to return to their habitual health status. however, little evidence exists on the putative benefits for elderly patients treated in a qdu setting. in this study, we will examine the benefits and drawbacks of treatment of elderly medical patients (≥75 years) in an acute treatment system with the possibility of fast-track admission and treatment, rather than treatment in the traditional medical system. we will randomise patients to treatment in either a fast track ward/short stay unit, the qdu, or to standard treatment at the dept. of internal medicine (dim). we hypothesise that treatment in a qdu compared to dim offers optimised care through immediate access to clinical staff and rapid diagnostic facilities, treatment and quicker rehabilitation.

Eligibility criteria:
inclusion criteria: 1. age ≥ 75 years 2. admitted for in-hospital treatment for an internal medicine disease 3. green tag triaged upon arrival in the ed exclusion criteria: 1. previous participation in this trial 2. participation in other clinical trials 3. no qdu beds available 4. subject does not have a danish civil registration number (cpr). 5. subject resides abroad 6. requires help using the toilet in daily life 7. patients not aware of date, time and location, or their own data (name, birth date) 8. informed consent cannot be obtained

Keywords: elderly quick diagnostic unit short stay unit randomised controlled trial
efficacy of negative pressure wound therapy after total ankle arthroplasty

Conditions: Ankle Disease

Summary: about 500 total ankle prostheses are implanted each year in france. wound healing issues are the most common complications after total ankle arthroplasty (taa). in 2010, a french retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. wound infection rate can vary up to 28% from the data available in the literature. delayed wound healing is a known risk factor of surgical site infection (ssi). even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation. negative pressure wound therapy (npwt) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. the wound is filled with wound filler and sealed with an airtight adhesive drape. it allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection. incisional npwt can accelerate wound healing regardless of the surgery performed, including orthopedics. a retrospective study compared the incidence of healing complications after taa between the administration of the npwt pico™ (smith\&nephew) and the standard of care of postoperative wounds in 74 patients. a significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of ssi (3% vs. 8%, respectively) were observed. to the investigator knowledge, no randomized study has been conducted to assess the efficacy of the npwt pico™ for postoperative wound healing after taa: investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the pico™ system after taa would reduce delayed wound healing compared to the standard of care with conventional dressings.


Eligibility criteria:
inclusion criteria: * patient aged 18 years or older * patient for whom a total ankle arthroplasty has been scheduled * patient affiliated to a national health insurance scheme or similar * patient who have signed an informed consent form for its participation in the study exclusion criteria: * patient with contraindication to use of the pico™ device * patient participating in another study including an exclusion period in progress * patient participating in another interventional study that may interfere with this research * adult patient protected by law, under guardianship or tutorship ; * pregnant or breastfeeding women.
effectiveness and safety of intra-articular semical gel-b cross therapy in knee osteoarthritis (sem-art1)

Conditions: Knee Osteoarthritis

Summary: the goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; semical gel-b cross, in knee osteoarthritis. primary objectives: the aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of semical gel b-cross, produced and marketed by semical biosurgery incorporated company, in knee osteoarthritis patients. it is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (semical gel-b cross); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.

the study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. after a maximum screening period of 28 days, patients with kellgren \& lawrence stage ii and iii knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered day 0. these treatment arms are: group 1: treatment arm - cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid) group 2: control arm - intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) a safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. in addition, an inquiry for injection-related adverse events will also be conducted. treatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria. at the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. efficacy evaluations will continue to be made at every three months for one year.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over, both male and female * diagnosed with clinical knee osteoarthritis according to the american college of * rheumatology (acr) criteria, with kellgren \& lawrence stage ii and iii osteoarthritic findings on antero-posterior knee radiographs * able to provide written informed consent exclusion criteria: -

Keywords: knee osteoarthritis hyaluronic acid intraarticular injection viscosupplementation